Durvalumab +/− Lenalidomide for T-Cell Lymphoma

Recruiting at3 trial locations

Overseen by Christiane Querfeld, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase I/II trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma.

Research Team

Christiane Querfeld, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with relapsed or refractory cutaneous or peripheral T cell lymphoma. Eligible participants must have confirmed mycosis fungoides (MF) or Sezary syndrome (SS), measurable disease, and adequate organ function. They should not have had certain treatments recently and must be willing to use birth control. Exclusions include prior stem cell transplantation, active infections like HIV, unstable heart disease, severe allergies to similar drugs, and other conditions that could affect safety.

Inclusion Criteria

I have recovered from side effects of previous treatments, except for hair loss.

I am a woman who can have children and my pregnancy test is negative.

My condition is confirmed as mycosis fungoides or Sezary syndrome, and it's at an advanced stage.

Exclusion Criteria

Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures

I am currently being treated for a serious infection.

I do not have a stomach or bowel condition that affects how my body absorbs medication.

Treatment Details

Interventions

• Durvalumab (Monoclonal Antibodies)
• Lenalidomide (Immunomodulatory agents)

Trial Overview The trial is testing the effectiveness of durvalumab alone versus in combination with lenalidomide in treating T cell lymphoma that has returned after treatment. Durvalumab is a monoclonal antibody that may block cancer growth by targeting specific cells, while lenalidomide can stop cancer cells from growing by various mechanisms.

Participant Groups

Group I: Arm II (durvalumab, lenalidomide) Experimental Treatment 3 Interventions

Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (durvalumab) Experimental Treatment 2 Interventions

Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School